Status:
COMPLETED
An Efficacy and Safety Study of Galantamine for the Treatment of Patients With Alzheimer's Disease
Lead Sponsor:
Janssen Pharmaceutical K.K.
Conditions:
Alzheimer's Disease
Eligibility:
All Genders
45+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of two fixed doses (16mg/day and 24mg/day) of galantamine (a drug for treating dementia) versus placebo for the treatment of patients w...
Detailed Description
This is a randomized (study drug assigned by chance), double-blind (neither the physician nor the patient know the name of the study medication), placebo-controlled, parallel-group study to evaluate t...
Eligibility Criteria
Inclusion
- Outpatients with a diagnosis of Alzheimer's disease according to the National Institute of Neurological and Communicative Disorders and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria
- Having a Mini-Mental Status Examination (MMSE) score of 10 - 22 inclusive
- Having an Alzheimer's Disease Assessment Scale - Japan cognitive subscale (ADAS-J cog) score of at least 18
- Exhibiting an onset and progression of cognitive dysfunction during at least 6 months prior to the screening period
Exclusion
- Patients with neurodegenerative diseases other than Alzheimer's disease, such as Lewy bodies disease, (dementia due to tiny round structures made of proteins that develop within nerve cells in the brain), Parkinsonism, etc
- Patients with cognitive dysfunction due to cerebral damage resulting from a lack of oxygen, a brain injury, etc
- Patients with multi-infarct dementia (brought on by a series of strokes) or active cerebrovascular disease
- Patients with clinically significant cardiovascular disease
- Patients currently taking drugs such as a cholinesterase inhibitors, which improve cerebral circulation/metabolism
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
580 Patients enrolled
Trial Details
Trial ID
NCT00814801
Start Date
February 1 2007
End Date
September 1 2008
Last Update
April 17 2014
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Fukuoka, Japan